Dioxin Developments

December 27, 2015 | Complex Torts & Product Liability

EFSA Concludes that Glyphosate Is “Unlikely to Pose a Carcinogenic Hazard to Humans”

The European Food Safety Authority (“EFSA”) has concluded its peer review of the pesticide risk assessment of glyphosate as requested by the European Commission (“EC”) and has concluded that glyphosate is “unlikely to pose a carcinogenic hazard to humans” and that the evidence “does not support classification with regard to its carcinogenic potential according to Regulation (EC) No 1272/2008.”

Background

EC Regulation (EU) No 1141/2010 (the “Regulation”), as amended by EC Implementing Regulation (EU) No 380/2013, explains the rules for renewing the approval of certain “active substances” for use in EU Member States, and establishes the list of those substances. The herbicide glyphosate is one of the active substances listed in the Regulation.

In accordance with Article 9 of the Regulation, Germany (the “RMS”) received an application from the European Glyphosate Task Force, a consortium of companies, seeking to renew the European glyphosate registration.  As of September 1, 2015, companies in the Task Force included ADAMA Deutschland GmbH, Agria S.A., Agro Trade GmbH, Albaugh UK Limited, Arysta Lifesciences SAS, Barclay Chemicals (Manufacturing) Ltd., Brokden SL, Bros Spolka Jawna B. P. Miranowscy, Cheminova A/S, Coromandel International Limited, Dow AgroSciences LLC, EXCEL CROP CARE (Europe) NV, Helm AG, Industrias Afrasa S.A., Monsanto Europe S.A./N.V., Nufarm GmbH & Co KG, Rotam Agrochemical Europe Limited, Sapec Agro S.A., Sinon Corporation, Société Financière de Pontarlier, Syngenta Limited, United Phosphorus Ltd, and Wynca UK Limited.

The RMS provided its initial evaluation of the available information on glyphosate, which the EFSA received on December 20, 2013. The EFSA initiated a peer review on January 22, 2014, including a public consultation.

The EFSA received comments, which it forwarded to the RMS for compilation and evaluation; the applicants were invited to respond to the comments.

On the basis of the comments received, the applicants’ response to the comments, and the RMS’s evaluation thereof, it was concluded that additional information should be requested from the applicants and that the EFSA should organize an expert consultation in the areas of mammalian toxicology, residues, environmental fate and behavior, and ecotoxicology. On August 6, 2014, the EFSA received a mandate from the EC for the peer review of the active substance glyphosate.

Then, on April 30, 2015, the EFSA received another mandate from the EC to consider the findings by the International Agency for Research on Cancer (“IARC”) regarding the potential carcinogenicity of glyphosate or glyphosate containing plant protection products in the on-going peer review of the active substance. (The IARC classified glyphosate as “probably carcinogenic to humans” (Group 2A).) The EFSA accepted the mandate on May 19, 2015 and included its views in the conclusion of the peer review.

Now, the EFSA has issued its report summarizing the outcome of the peer review of the risk assessment on glyphosate.

The EFSA’s Conclusions

The EFSA reached its conclusions on the basis of the evaluation of the representative uses of glyphosate as a herbicide on emerged annual, perennial, and biennial weeds in all crops – including root and tuber vegetables, bulb vegetables, stem vegetables, field vegetables (fruiting vegetables, brassica vegetables, leaf vegetables and fresh herbs, legume vegetables), pulses, oil seeds, potatoes, cereals, and sugar- and fodder-beet; orchard crops and vine, before planting fruit crops, ornamentals, trees, nursery plants, etc. – and foliar spraying for desiccation in cereals and oilseeds (pre-harvest), as proposed by the applicants.

The EFSA concluded that glyphosate was “unlikely to pose a carcinogenic hazard to humans” and that the evidence did “not support classification with regard to its carcinogenic potential according to Regulation (EC) No 1272/2008.” As the EFSA report specifically stated:

“Glyphosate is not classified or proposed to be classified as carcinogenic or toxic for the reproduction category 2 in accordance with the provisions of Regulation (EC) No. 1272/2008 … and therefore the conditions of the interim provisions of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 concerning human health for the consideration of endocrine disrupting properties are not met.”

In summary, considering a “weight of evidence approach” and “taking into account the quality and reliability of all available data,” the EFSA peer review concluded that glyphosate is unlikely to be genotoxic in vivo and that it does not require hazard classification regarding mutagenicity.

Learn more: “Monsanto Empanels Group to Review IARC Classification of Glyphosate,” at http://www.rivkinradler.com/publications/international-dioxin-developments-3/

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WHO Estimates “Disease Burden” of Four Chemicals

A research article by the World Health Organization (“WHO”) Foodborne Disease Burden Epidemiology Reference Group (“FERG”) Task Forces said that it has estimated the “global and regional disease burden” of four “foodborne chemical toxins” –cyanide in cassava, peanut allergen, aflatoxin, and dioxin.

Background

The research article, which still is awaiting peer review, is entitled, “World Health Organization estimates of the global and regional disease burden of four foodborne chemical toxins, 2010: a data synthesis.” The article’s authors are listed as Herman Gibb, Brecht Devleesschauwer, P. Michael Bolger, Felicia Wu, Janine Ezendam, Julie Cliff, Marco Zeilmaker, Philippe Verger, John Pitt, Janis Baines, Gabriel Adegoke, Reza Afshari, Yan Liu, Bas Bokkers, Henk van Loveren, Marcel Mengelers, Esther Brandon, Arie H. Havelaar, and David Bellinger. The authors are from 18 institutions in eight different countries, ranging from Gibb Epidemiology Consulting LLC in Arlington, Virginia, and the Department of Virology, Parasitology and Immunology at Ghent University in Merelbeke, Belgium, to the Institute for Risk Assessment Sciences at Utrecht University in Utrecht, the Netherlands, and the Boston Children’s Hospital in Boston, Massachusetts.

The article began by declaring that chemical exposures “have been associated with a variety of health effects” but that “little is known about the global disease burden from foodborne chemicals.” It added that food “can be a major pathway for the general population’s exposure to chemicals, and for some chemicals, it accounts for almost 100% of exposure.”

The researchers said that they evaluated four chemicals – as noted above, they were cyanide in cassava, peanut allergen, aflatoxin, and dioxin – for their ability to “contribute to the burden of disease.” They said that they reviewed the literature to develop age- and sex-specific disease incidence and mortality estimates due to these chemicals. From these estimates, the authors added, they calculated the numbers of cases, deaths, and disability adjusted life years (“DALYs”).

The Article’s Conclusions

The article estimated that, for these four chemicals combined, the total number of illnesses, deaths, and DALYs in 2010 was 339,000 (95% uncertainty interval (“UI”): 186,000-1,239,000); 20,000 (95% UI: 8,000-52,000); and 1,012,000 (95% UI: 562,000-2,822,000), respectively.

The article said that cyanide in cassava and aflatoxin were associated with diseases with high case-fatality ratios and that “[v]irtually all human exposure to these four chemicals is through the food supply.”

It also stated that the case-fatality rates for these four chemicals ranged from low (e.g., peanut allergen) to extremely high (aflatoxin and liver cancer) and that the effects associated with these four chemicals were “neurologic (cyanide in cassava), cancer (aflatoxin), allergic response (peanut allergen), endocrine (dioxin), and reproductive (dioxin).”

According to the article, the chemical associated with the most number of illnesses was dioxin (193,447; 95% UI: 155,963-1,085,675), although, it said, “no deaths have been reported from the presence of dioxin in the food supply.” The article also said that the chemical associated with the greatest number of DALYs was aflatoxin.

According to the article, the regions with the “highest burden per 100,000 inhabitants” were the Southeast Asia Region (“SEAR”), Western Pacific Region (“WPR”), and the African Region (“AFR”) and that the Americans Region (“AMR”), Eastern Mediterranean Region (“EMR”), and Europe (“EUR”) had the lowest DALYs per 100,000. In addition, according to the article:

  • Aflatoxin was the largest contributor to the burden in the AFR and the WPR;
  • Dioxin made the largest contribution in the SEAR;
  • Virtually all of the DALYs for aflatoxin and most of the DALYs for cyanide in cassava were due to years of life lost (“YLL”), whereas most of the DALYs for peanut allergen and all of the DALYs for dioxin were due to years lived with disability (“YLD”).

The article is:Gibb H, Devleesschauwer B, Bolger PM et al. World Health Organization estimates of the global and regional disease burden of four foodborne chemical toxins, 2010: a data synthesis [version 1; referees: awaiting peer review] F1000Research 2015, 4:1393 (doi: 10.12688/f1000research.7340.1).

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Groups to Put Monsanto on Mock “Trial” for “Crimes against Humanity and the Environment”

A number of organizations have announced that they will put Monsanto on “trial” for “crimes against nature and humanity, and ecocide.” They said that the mock trial is scheduled to take place in The Hague, Netherlands, on “World Food Day,” October 16, 2016.

Background

The announcement, by the Organic Consumers Association (“OCA”), IFOAM International Organics, Navdanya, Regeneration International (“RI”), and Millions Against Monsanto, was made at a press conference in Paris during the United Nations Conference on Climate Change.

Speaking at the press conference, Ronnie Cummins, international director of the OCA (US) and Via Organica (Mexico), and a member of the RI steering committee, said, “The time is long overdue for a global citizens’ tribunal to put Monsanto on trial for crimes against humanity and the environment. We are in Paris this month to address the most serious threat that humans have ever faced in our 100-200,000 year evolution – global warming and climate disruption. Why is there so much carbon dioxide, methane and nitrous oxide in the atmosphere and not enough carbon organic matter in the soil? Corporate agribusiness, industrial forestry, the garbage and sewage industry and agricultural biotechnology have literally killed the climate-stabilizing, carbon-sink capacity of the Earth’s living soil.”

Vandana Shiva, the founder of Navdanya and a member of the RI steering committee said, “Monsanto has pushed GMOs in order to collect royalties from poor farmers, trapping them in unpayable debt, and pushing them to suicide. Monsanto promotes an agro-industrial model that contributes at least 50 percent of global anthropogenic greenhouse gas emissions. Monsanto is also largely responsible for the depletion of soil and water resources, species extinction and declining biodiversity, and the displacement of millions of small farmers worldwide.”

The announcement criticized Monsanto for products including PCBs (polychlorinated biphenyl); 2,4,5-trichlorophenoxyacetic acid; the herbicide Lasso; and RoundUp, which it characterized as “the most widely used herbicide in the world, and the source of the greatest health and environmental scandal in modern history.”

The announcement said that the mock trial will involve an “international court of lawyers and judges will assess the potential criminal liability of Monsanto for damages inflicted on human health and the environment.” It said that the “court will also rely on the Rome Statute that created the International Criminal Court in The Hague in 2002, and it will consider whether to reform international criminal law to include crimes against the environment, or ecocide, as a prosecutable criminal offense.”

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